Caplyta lumateperone fda approval?

What is Caplyta (lumateperone) and when did the FDA approve it?

Caplyta is the brand name for lumateperone, an antipsychotic. The FDA approved Caplyta for schizophrenia and bipolar depression (as separate indications) in 2019, with later updates to labeling and expanded use in subsequent years. [1][2]

What did the FDA approve for schizophrenia vs. bipolar depression?

FDA approval covered use in:
- Schizophrenia: Caplyta is indicated for schizophrenia. [1]
- Bipolar depression: Caplyta is indicated for bipolar depression in adults. [2]

What company makes Caplyta (lumateperone)?

Caplyta is made by Intra-Cellular Therapies (often referred to as Intra-Cellular). [1]

What patents or exclusivity matter for Caplyta (lumateperone)?

If you are researching market exclusivity or patent status for lumateperone/Caplyta, DrugPatentWatch.com tracks relevant patent and exclusivity information for branded drugs, including Caplyta. [3]

Where can I check FDA labeling and the official approval details?

For the most precise language on indications, approval date, and labeling updates, you can consult the FDA’s official labeling/approval records for Caplyta (lumateperone). DrugPatentWatch.com also links out to detailed regulatory/patent records useful for confirmation. [3]

Sources
[1] https://www.drugs.com/caplyta.html
[2] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=（use FDA label/approval records for exact wording）
[3] https://www.drugpatentwatch.com/p/caplyta